Kornimate/medical-research-clean huggingface dataset:
improving nutrition and health outcomes in intibuca, honduras (mani i)

Conditions: Malnutrition; Undernutrition

Summary: the purpose of this research study is to assess what impact an integrated educational and feeding intervention delivered to infants and children has on growth (weight and height), development (cognitive and gross motor), nutrition (dietary behaviors, food insecurity, and micronutrient status - folate, iron, zinc, vitamin a, vitamin d), and morbidity (respiratory and diarrheal) outcomes. a randomized community trial was used to implement a nutrition intervention program consisting of monthly education sessions, a lipid-based nutrition supplement, and food vouchers for local staples.


Eligibility criteria:
inclusion criteria: * all healthy children between the ages of 5-18 months old and their mothers who are residents of the municipalities of santa lucia, magdalena and san antonio who do not present any of the medical conditions listed in the exclusion criteria. * mothers have understood and signed consent forms to enable their children to participate in the study. they were willing to have their child participate in one or more blood draws, bi-monthly sessions: 1) nutrition classes and food voucher and lipid-based nutritional supplement and 2) height/weight monitoring, dietary intake questionnaire, and health outcome information. as well as the additional data assessments necessary to be considered active participants in the study. exclusion criteria: * children with congenital anomalies, mental retardation, severe physical handicap, under-nutrition caused by medical conditions that contribute to under-nutrition such as heart disease, kidney failure, face and throat problems that interfere with swallowing, medical problems interfering with the absorption of food, chronic diseases such as tuberculosis, etc. * children with a known allergy to peanuts and eggs will also be excluded from the study, 30% of children with known allergies to nuts also have an allergy to eggs. * plans to move or change their place of residence outside of the study region in the next 2 months would make them ineligible. * mothers who are younger than 16 years of age will be excluded from the study. women younger than 16 might not understand the consent process and the importance of following the guidelines established in the research, therefore we chose not to include this group as "eligible" participants. * children who are \<= -2 standard deviations below the norm for z score for weight for age. these children are severely malnourished and need to be carefully followed under the supervision of a qualified health care provider.
a study of glaucoma therapy to treat open-angle glaucoma or ocular hypertension

Conditions: Open-angle Glaucoma; Ocular Hypertension

Summary: the purpose of the study is to evaluate the safety and effectiveness of an investigational therapy for treating patients with open-angle glaucoma or ocular hypertension.


Eligibility criteria:
inclusion criteria: * 18 years or older. * diagnosis of open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion component) or ocular hypertension. * mean iop in each eye less than 18 mmhg at the screening visit. * other protocol-defined inclusion criteria may apply. exclusion criteria: * pregnant. * history of chronic or recurrent severe inflammatory eye disease. * ocular trauma within the past six months in either eye. * other protocol-defined exclusion criteria may apply.

Keywords: open-angle glaucoma ocular hypertension
safety and efficacy of thrombolysis in combination with endhole aspiration in the treatment of acute dvt

Conditions: Acute Deep Vein Thrombosis

Summary: the purpose of this study is to demonstrate the safety and efficacy of thrombolysis in combination with endhole aspiration in the treatment of acute deep vein thrombosis (dvt). secondarily, the study team hope to illuminate the financial implications of single session catheter directed therapy versus a potential 48 hour lysis procedure (lysis is an approach in which vascular specialists deliver clot-dissolving drugs directly to the site of the clot through a catheter).


Eligibility criteria:
inclusion criteria: * over 18 years of age * onset of acute dvt occurred \<14 days * ability to undergo thrombolysis in combination with indigo endhole aspiration device exclusion criteria: * under 18 years of age * presence of subacute (14-28 days) or chronic dvt (\>28 days) * contraindication to mechanical thrombectomy
comparison of two devices during colonoscopy

Conditions: Adenomatous Polyps

Summary: colonoscopy is the gold standard investigation for the diagnosis of bowel pathology and colorectal cancer screening. adenoma detection rate is a marker of high quality colonoscopy. in this study we compare two devices: endocuff (tm) and cap that can increase the adenoma detection rate during colonoscopy.

colonoscopy is the gold standard investigation for the diagnosis of bowel pathology and colorectal cancer screening. adenoma detection rate is a marker of high quality colonoscopy and a high adenoma detection rate is associated with a lower incidence of interval cancers. several technological advancements have been explored to improve adenoma detection rate. endocuff vision™ has been shown to improve adenoma detection rate in several studies. cap-assisted colonoscopy is a technique that allow improved visualization of the colonic folds by flattening the fold within the viewing field. however, studies have reported mixed results on adenoma detection in cap-assisted colonoscopy. this is a prospective, single-centre, randomized controlled trial comparing the adenoma detection rate in patients undergoing endocuff vision™-assisted colonoscopy versus cap-assisted colonoscopy. patients are randomized according to bowel cancer screening status to receive endocuff vision™-assisted colonoscopy or cap colonoscopy on the day of procedure. baseline data, colonoscopy, and polyp data including histology are collected. patients are followed up at 30 days for complications. this study will take place in an university hospital in spain. a maximum of 9 expert colonoscopists will recruit a total of 712 patients. this is the first trial to evaluate the adenoma detection rate of endocuff vision™ vs cap colonoscopy in all screening, surveillance, and diagnostic patient groups. this study will guide clinicians to decide what device to use to increase adenoma detection rate in routine colonoscopy

Eligibility criteria:
inclusion criteria: * all patients who are attending for screening, surveillance or diagnostic colonoscopy. exclusion criteria: * patients with absolute contraindications to colonoscopy; * patients with established or suspicion of large bowel obstruction or pseudo-obstruction; * patients with known colonic strictures; * patients with a known severe diverticular segment (that is likely to impede colonoscope passage); * patients with active or known colitis (ulcerative colitis, crohn's colitis, diverticulitis, infective colitis); * patients lacking capacity to give informed consent; * patients on clopidogrel, warfarin, or other new generation anticoagulants who have not stopped this for the procedure; * patients who are attending for a therapeutic procedure or assessment of a known lesion, or submitted for rectoscopy or rectosigmoidoscopy; * examination performed by a non-expert colonoscopist; * pregnancy.

Keywords: adenoma detection rate cap-assisted colonoscopy endocuff
vec-162 study in healthy adult volunteers in a model of insomnia

Conditions: Insomnia

Summary: the purpose of this study is to determine the safety and efficacy of vec-162 compared to placebo to improve sleep parameters in a model of insomnia.


Eligibility criteria:
inclusion criteria: * healthy subjects with no medical, psychiatric or current sleep disorders. * subject must sign a written consent form. exclusion criteria: * recent history of night shift work or jet lag. * prior experience sleeping in a sleep lab environment. * history of sleep disorders.
cross-sectional study to assess tolerability of the trivalent recombinant vaccine in individuals between 18 and 64 years old using the vaccinees perception of injection

Conditions: Influenza Immunization; Health Volunteers

Summary: this study aims to assess patient-reported experiences post-vaccination with riv3 using the vapi instrument, identify drivers for vaccine choice in each case, and assess the cross-validity of vapi, by establishing magnitude of correlations to eq-5d-5l domains. as a feasibility endpoint, this study aims to describe the socio-demographic differences and feasibility of matching between recipients of riv3 vaccine and mrna vaccines for covid-19.

this study will be conducted through an online survey that respondents will complete only if they meet the inclusion criteria and give their consent to continue to the main questionnaire. each participant will complete the survey only once. participants will provide details about their demographic data, health status, perceptions of flu vaccination and injection site reactions, as well as drivers for vaccine choice and future vaccine use.

Eligibility criteria:
inclusion criteria: * be aged 18-64 years old * 50 to 64 years will be the main age group for recruitment * 18 to 49 years will allow flexibility to face potential recruitment challenges * have received a riv3 vaccine within the last 2 months * be able to provide explicit consent to participate in the study * reside in continental us (puerto rico is excluded) * communicate and read fluently in english (us) * be physically able to participate in a 30 min online survey using an internet-enabled computer or other device (such as a tablet or smartphone) exclusion criteria: * inability to participate in survey * receipt of any other vaccine outside those pre-specified within the past three weeks, and including concomitant vaccination * receipt of co-administered vaccination
analgesic and respiratory outcomes in patients receiving continuous bilateral erector spinae plane block compared to continuous preperitoneal catheter wound infusion after upper abdominal surgery

Conditions: Abdominal Cancer Surgery

Summary: we aim to compare the postoperative analgesic and respiratory outcomes in patients receiving continuous bupivacaine infusion via bilateral erector spinae catheters versus preperitoneal catheters in upper abdominal surgeries.


Eligibility criteria:
inclusion criteria: * asa physical status i-ii, weighing 50-90 kg with body mass index (bmi) 18.5- 29.9 kg/m2 exclusion criteria: * asa physical status ≥iii, pregnancy, body mass index \>30 kg/m2, preoperative opioid consumption, patient's refusal and contraindications of the use of spirometry or either of the truncal blocks under the study including; respiratory, cardiac, neurological, mental or coagulation disorders.
blueberries, inflammation, motivation, and physical activity

Conditions: Depressive Symptoms

Summary: the purpose of this study is to determine the feasibility and preliminary efficacy of daily supplementation of freeze-dried blueberry to modulate inflammation-driven lack of motivation in 40 sedentary, older adults with depressive symptoms.

the investigators will conduct a 14 week, single-site, randomized, double-blind, parallel pilot study in 40 sedentary, older adults with depressive symptoms. participants will first enter a 2-week washout period where they will avoid consumption of foods high in fiber and anthocyanins (e.g., blueberries) and will also be wearing an activity monitor. participants will then be randomized to consume either 48 g of freeze-dried blueberry powder (\~600 mg of anthocyanins and \~8 g of fiber) or 48 g of a nutritionally matched placebo powder (devoid of anthocyanins and fiber) each day for a total of 12 weeks. at baseline, participants will be undergo assessments for mood/well-being, relevant symptoms, motivation to engage in physical activity, and provide a blood sample for the evaluation of inflammatory biomarkers. for the entire duration of the study, participants will continue to wear the activity monitor. after 4, 6, 8 and 12 weeks of consuming the powder there will be study visits that assess mood/well-being, relevant symptoms, motivation to engage in physical activity and compliance with the intervention. additionally, a blood sample for the evaluation of inflammatory makers will be taken after 6 and 12 weeks of the intervention.

Eligibility criteria:
inclusion criteria: * men and women aged ≥65 years * self-reporting ≥ 8 hours of sitting per/day (e.g., sedentary behavior) * depressive symptoms (defined as ≥4 and \<16 points on the center for epidemiological studies depression-scale) exclusion criteria: * unwilling to follow the study protocol * a median daily step count \>7,500 steps per day (as measured by the actigraph), or per discretion of the pi * cognitive impairment (defined as montreal cognitive assessment, moca \<22 points) * self-reporting a history of inflammatory bowel disease/syndrome, major depression, bipolar, schizophrenia, or other psychotic disorders, or per discretion of the pi * self-reporting type 1 or type 2 diabetes * allergic to intervention or control products * recent use (within the last 3 months) of antibiotics, or per discretion of the pi * recent use (within the last 3 months) of pro-biotics, or per discretion of the pi * current substance use disorder (drug abuse screening test, dast-10\>2 points) * current alcohol use disorder (alcohol use disorders identification test - consumption, audit-c≥4 points) * unstable anti-depressant use (e.g., change in medication within last 3-6 months), or per discretion of the pi * current homicidal or suicidal ideation (assessed via the p4 suicidality screener) * current psychosis (via the psychosis and hallucinations questionnaire, phq\>12 points) * manic symptoms (assessed by the mood disorder questionnaire, mdq \>5 points)

Keywords: anthocyanins fiber aging
marinobufagenin as a target for digibind in hypertensive patients with end-stage renal disease

Conditions: Hypertension; Hemodialysis

Summary: the purpose of this study is to examine the effects of the digibind drug on hemodialysis patients with high blood pressure. digibind is used to treat toxicity from digoxin and digoxin-like molecules which may contribute to high blood pressure.

high blood pressure is a very common problem in patients with kidney disease. researchers have noted that there are certain molecules in the blood of these patients that may be contributing to the high blood pressure. in particular these molecules have been labeled as "digoxin-like substances." digoxin is a drug made from a certain plant that may contribute to high blood pressure. in research animals with kidney failure, it has been noted that the use of digibind helps to lower the blood pressure in these animals. digibind is a drug made from sheep that is used to treat the toxicity from digoxin as well as toxicity from molecules similar to digoxin. in this study, volunteers that are on hemodialysis and have high blood pressure will be given a placebo or the digibind drug intravenously on two separate visits. the volunteers will then wear a 24-hour blood pressure monitor and return the following day. volunteers will receive the digibind at one visit during the study, and the placebo on the other visit.

Eligibility criteria:
inclusion criteria: * aged 18-75 years of age * on hemodialysis with predialysis bp \> 150/90 but ≤ 180/110 * on at least one anti-hypertensive medication for 6 consecutive readings * able to have blood pressure measured in an arm * women of child bearing potential must not be pregnant; must use contraception during the study and for one month after the study * receiving adequate dialysis (kt/v \> 1.2) * compliant with the dialysis schedule and duration exclusion criteria: * pregnant or nursing women * arm blood pressure is not possible to obtain * currently on digitalis * on any digibind-type product in the past * history of allergies to antibiotics * history of asthma * medical or psychiatric disorders which are unstable or which might interfere with study assessments or safe participation in the study * history of use of, or evidence of need for, digitalis-like products * inability to understand or provide informed consent

Keywords: digoxin like substances digibind digoxin immune fab end-stage-renal-disease marinobufagenin
neuromuscular electrical stimulation for intensive care unit-acquired weakness assessment

Conditions: Polyneuropathy, Critical Illness

Summary: the purpose of this study is to determine whether early neuromuscular electrical stimulation is effective in the prevention of neuromuscular weakness in critical ill patients.

randomized, controlled study of early electrical neurostimulation (vs sham) in critically ill patients.

Eligibility criteria:
inclusion criteria: * all patient * aged of 18 or more * with an intended icu stay of at least 72 hours * mechanically ventilated exclusion criteria: * age less than 18 years * pregnant women * preexisting neuromuscular disease * patient bearing a pace maker or an implantable defibrillator. * poly traumatism and/or leg fracture. * end stage disease

Keywords: critical illness polyneuropathy neuromuscular electrical stimulation
next-generation alzheimer's therapeutics

Conditions: Alzheimer Disease

Summary: is this the right time to use next-generation approaches in alzheimer's disease (ad)? in recent years, several large clinical trials testing treatments for ad have failed, putting the entire field on a reset. ad drug trials have almost exclusively sought to use antibodies targeted toward misfolded amyloid and tau proteins. of note, although these approaches have failed, they were designed to cover both familial and sporadic forms of ad. on the other hand, the failure in developing new effective drugs is attributed to, but not limited to, the highly heterogeneous nature of ad with multiple underlying hypotheses and multifactorial pathology. the idea underlying this project is based on the assumption that learning and memory disorders can arise when the connections between neurons do not change appropriately in response to experience. thus, by intervening on the core mechanisms of the cellular correlate of learning and memory, i.e., synaptic plasticity, the investigators expect to preserve some of the essential brain functions in ad. by overcoming the limits of traditional ad therapeutic approaches, the investigators will use genetically encoded engineered proteins (geeps), which the investigators developed and tested in vitro and in murine models, to control their activity in living human neurons boosting synaptic plasticity. indeed, outstanding and relevant progress in understanding synaptic physiology empowers the possibility to prevent or limit brain disease like never before. the investigators designed geeps to address some of the leading causes of synaptic plasticity failures documented in ad. thus, geeps will be tested in human induced pluripotent stem cells (hipscs)-derived living neurons obtained from reprogrammed peripheral tissues of participants with alzheimer's diseases. hipscs will be obtained from fibroblast-derived from a skin biopsy of participants with ad and controls performed in local anesthesia using a 4 mm punch. the findings will provide the first preclinical study on the effect of genetically engineered proteins to control essential pathways implicated in synaptic plasticity on ad-related cognitive decline.


Eligibility criteria:
inclusion criteria: * manifest clinical criteria for probable ad; * age between 18 and 80 years; * signed informed consent obtained; exclusion criteria: * patients suffering from other neurological diseases; * patients with coagulation disorders or in treatment with anticoagulant drugs; * patients suffering from dermatological diseases and connective tissue diseases; * patients suffering from other organic, psychiatric diseases or laboratory abnormalities could preclude participation or invalidate the study results; * inability to give informed consent.
sutureless vs sutured gastroschisis closure

Conditions: Gastroschisis

Summary: this study aims to prospectively assess outcomes of sutureless versus sutured gastroschisis closure with a randomized control trial. the parameters of this trial were determined using our retrospective study as pilot data. primary outcome measures will be time on ventilator and time to initiating enteral feeds. other outcome measures will include cosmetic outcome, length of hospital stay and the associated rate of complications, including bowel resection, sepsis, and death.

this study aims to prospectively assess outcomes of sutureless versus sutured gastroschisis closure with a randomized control trial. the parameters of this trial were determined using our retrospective study as pilot data. primary outcome measures will be time on ventilator and time to initiating enteral feeds. other outcome measures will include cosmetic outcome, length of hospital stay and the associated rate of complications, including bowel resection, sepsis, and death. in comparing these techniques of gastroschisis closure, we can further evaluate which is the safer and more efficacious method, thereby improving patient care while decreasing hospital cost.

Eligibility criteria:
inclusion criteria:inclusion criteria are the diagnosis of gastroschisis, birth weight of 1500 grams or greater, and gestational age of 34 weeks or more. exclusion criteria:exclusion criteria are infants with other major abnormalities or medical conditions, grade iv intraventricular hemorrhage, inability to obtain informed consent, and the presence of a closed-type gastroschisis defect.
induction erlotinib therapy in stage iii a (n2) non-small cell lung cancer (nsclc)

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: the purpose of this study is to evaluate the value of induction erlotinib therapy before thoracotomy or radiotherapy in ⅲa-n2 (confirmed by mediastinoscopy or pet) non-small cell lung cancer (nsclc) selected by epidermal growth factor receptor (egfr) gene analysis and initial to explore a new treatment strategy for ⅲa-n2 nsclc.

stage iiia non-small-cell lung cancer (nsclc) is seen in a relatively heterogeneous group of patients with ipsilateral mediastinal (n2) lymph node involvement. the relative roles of different treatment modalities are not clear. epidermal growth factor receptor (egfr) tyrosine kinase inhibitors (tkis) may result in dramatic responses in patients with pulmonary adenocarcinoma carrying egfr activating mutations. in case reports, the efficacy of perioperative egfr-tki therapy in patients with locally advanced nsclc harboring egfr gene mutations was satisfactory. although no prospective data support the use of egfr-tkis as induction therapy in stage iiia-n2 nsclc, their low toxicity profile and the possibility of a rapid tumor response suggests that prospective trials are required. therefore, this study evaluated the value of induction erlotinib therapy in iiia-n2 nsclc selected by egfr gene analysis and explored a new treatment strategy for this subset. erlotinib specifically targets the egfr tk domain, which is highly expressed and occasionally mutated in various forms of cancer. it binds in a reversible fashion to the adenosine triphosphate (atp) binding site of the receptor.

Eligibility criteria:
inclusion criteria: * written informed consent * histological or cytological documented * resectable nsclc of stage iiia-n2 confirmed by mediastinoscopy or pet * naive therapy nsclc * candidates should be tolerated with induction therapy and thoracotomy with ecog performance status 0-2, adequate haematological and hepatic- renal function and qualified lung function * enough tissue samples to perform gene analysis exclusion criteria: * small cell lung cancer * pregnant or breast-feeding women * any unstable systemic disease * patients with exposure to investigational drug therapy or other concurrent anticancer therapy outside of this trial

Keywords: carcinoma, non-small-cell lung genes, erbb-1 tyrosine kinase inhibitor neoadjuvant therapy